Human research rules to be revised

The Department of Health and Human Services has announced plans to improve the Common Rule, a set of regulations that facilitate how human research is conducted that have been in place since 1991.

“This regulatory review effort is primarily about enhancing protections for human subjects,” HHS assistant secretary for health Howard K. Koh, MD, MPH, said in a press release. “The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”

One of these challenges involves participant consent for how biospecimens can be used.

Under current rules, biospecimens such as blood and other bodily fluids that are collected for one study may be used in many others without explicit permission from the person to whom it belongs under the assumption that the specimen is “deidentified” from the subject.

But recent advances in genetic and DNA testing now make these specimens “inherently identifiable,” Kathy Hudson, PhD, deputy director for Science, Outreach, and Policy at the National Institutes of Health (NIH), explained in a press briefing.

Under the proposed HHS changes, researchers would be required to obtain participants' consent to use biospecimens in studies other than the one in which they are enrolled.

Another major revision would require all institutions that receive any federal funding, even in a branch not directly involved with the research in question, to follow federal guidelines pertaining to human research.

Currently, if a study is not funded by federal grant money and is not conducted as part of the FDA approval process, researchers are not required to abide by these guidelines.

Proposed changes to streamline study protocol include simplifying the institutional review board (IRB) process for multicenter studies. Instead of requiring approval from a unique IRB at each study site, which can be time-consuming, HHS has proposed a single IRB for the entire study, enabling more expedient patient enrollment.

Another provision included in the proposed rule would make requirements for studies that are unlikely to pose harm to human participants, such as surveys and research involving social science, less stringent.

The rule was published today in the Federal Register and is available online in it's entirety.  Those interested can submit a comment here, using the following identification number: HHS-OPHS-2011-0005.

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